Probelco S.A. de D.V.
⚠️ High Risk
FEI: 3002882705 • Ciudad De Mexico, Ciudad de Mexico • MEXICO
FEI Number
3002882705
Location
Ciudad De Mexico, Ciudad de Mexico
Country
MEXICOAddress
Calle Biznaga No. 43, Col. Las Palmas, Alvaro Obregon, Ciudad De Mexico, Ciudad de Mexico, Mexico
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
POISONOUS
The article is subject to refusal of admission pursuant Section 801(a)(3) in that The cosmetic appears to bear or contain a poisonous or deleterious substance which may render it injurious to users under the conditions prescribed in the labeling thereof, or, under such conditions of use as are customary or usual.
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
FILTH
The cosmetic appears to consist in whole or in part of any filthy, putrid, or decomposed substance.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/1/2011 | 53CD02EYELINER (EYE MAKEUP PREPARATIONS) | 310POISONOUS | Southwest Import District Office (SWI-DO) |
| 8/1/2011 | 53CI02EYELINER (EYE MAKEUP PREPARATIONS) | 310POISONOUS | Southwest Import District Office (SWI-DO) |
| 5/16/2008 | 53CD02EYELINER (EYE MAKEUP PREPARATIONS) | 310POISONOUS | Southwest Import District Office (SWI-DO) |
| 5/14/2008 | 53CD06MASCARA (EYE MAKEUP PREPARATIONS) | 310POISONOUS | Southwest Import District Office (SWI-DO) |
| 6/1/2006 | 53CK06MASCARA (EYE MAKEUP PREPARATIONS) | 310POISONOUS | Southwest Import District Office (SWI-DO) |
| 6/1/2006 | 53CK06MASCARA (EYE MAKEUP PREPARATIONS) | 310POISONOUS | Southwest Import District Office (SWI-DO) |
| 12/12/2005 | 53GH02FACE POWDERS (MAKEUP PREPARATIONS, NOT FOR EYES) | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 11/2/2005 | 53CK06MASCARA (EYE MAKEUP PREPARATIONS) | 310POISONOUS | Southwest Import District Office (SWI-DO) |
| 11/2/2005 | 53CK06MASCARA (EYE MAKEUP PREPARATIONS) | 310POISONOUS | Southwest Import District Office (SWI-DO) |
| 11/2/2005 | 53CK06MASCARA (EYE MAKEUP PREPARATIONS) | 310POISONOUS | Southwest Import District Office (SWI-DO) |
| 11/2/2005 | 53CK06MASCARA (EYE MAKEUP PREPARATIONS) | 310POISONOUS | Southwest Import District Office (SWI-DO) |
| 6/30/2005 | 53CK06MASCARA (EYE MAKEUP PREPARATIONS) | 310POISONOUS | Southwest Import District Office (SWI-DO) |
| 3/7/2005 | 53CY06MASCARA (EYE MAKEUP PREPARATIONS) | 473LABELING | Southwest Import District Office (SWI-DO) |
| 3/7/2005 | 53CY06MASCARA (EYE MAKEUP PREPARATIONS) | 312FILTH | Southwest Import District Office (SWI-DO) |
| 3/7/2005 | 53CY06MASCARA (EYE MAKEUP PREPARATIONS) | 310POISONOUS | Southwest Import District Office (SWI-DO) |
| 4/27/2004 | 53CI06MASCARA (EYE MAKEUP PREPARATIONS) | 471CSTIC LBLG | Southwest Import District Office (SWI-DO) |
| 4/14/2004 | 53CD02EYELINER (EYE MAKEUP PREPARATIONS) | 471CSTIC LBLG | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Probelco S.A. de D.V.'s FDA import refusal history?
Probelco S.A. de D.V. (FEI: 3002882705) has 17 FDA import refusal record(s) in our database, spanning from 4/14/2004 to 8/1/2011.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Probelco S.A. de D.V.'s FEI number is 3002882705.
What types of violations has Probelco S.A. de D.V. received?
Probelco S.A. de D.V. has been cited for 5 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Probelco S.A. de D.V. come from?
All FDA import refusal data for Probelco S.A. de D.V. is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.